Earlier this year, pharmaceutical giant Pfizer paid $2.3 billion to settle civil and criminal allegations that it engaged in off-label promotion to market one of its products. What is off-label promotion and why is it such a big deal? Many medical technology and life sciences companies understand the regulatory implications of off-label promotion but struggle with risk management strategies to prevent it. This webinar will provide information about off-label practices, the connection between off-label promotion and products liability, and techniques to avoid potential liability resulting from off-label promotion.
This webinar will provide you with actionable ways to mitigate these risks and will stress the importance of:
Kelly Savage Day represents clients in the pharmaceutical, manufacturing, transportation, computer, real estate and insurance industries. She has almost a decade of experience counseling and defending companies in state and federal court at both the trial and appellate level. She combines aggressive advocacy with practical, common sense advice to achieve the best results for her clients.
Ms. Day recently helped generic drug manufacturer Perrigo Pharmaceuticals Company (Perrigo) avoid several multi-million dollar claims by convincing the Northern District of California that plaintiffs' state-law claims against the generic drug manufacturer were preempted under the federal Food, Drug and Cosmetics Act (FDCA). The court's ruling has broad implications, because it is one of the first to explicitly recognize the preemptive effect of federal Food and Drug Administration's (FDA) labeling requirements with respect to generic drug manufacturers, who are required to provide the exact labeling information used by the brand name drug manufacturer — no less, but also no more. In the last year alone, she rescued a small local business from bankruptcy by persuading the California Court of Appeals to vacate a $1.7 million judgment in a high-profile employment case featured on both The Oprah Winfrey Show and Today Show. She also saved an international pharmaceutical company from hundreds of thousands in attorney's fees by persuading a trial court to dismiss a class-action complaint filed by plaintiffs claiming the company's warnings on prescription and non-prescription products violated California's Proposition 65 and the UCL. In both instances, Ms. Day worked closely with clients to control legal expenses and prevent wasteful and unnecessary activity.
Ms. Day is admitted to practice in California and Ohio. She is a member of the California Bar Association and is active in both professional and community activities. Ms. Day is a former state appellate court law clerk and federal district court law clerk. She is a contributing editor to one of the preeminent California appellate practice guides and frequently authors articles and makes presentations on a wide variety of issues.